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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 20:14

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169 device results listed.

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MTC-Q Real-Time PCR Kit

G2M707321

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707321FT
Basic UDI-DI: B-G2M707321FT
Reference: G2M707321,G2M707321R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: D-8908007989460CA
Basic UDI-DI: B-8908007989460CA
Reference: 601130005, 601130020, 601130025, 601130050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002RMTB01N5WX

RMTB01-AHG5E, RMTB01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002RMTB01N5WX
Basic UDI-DI: B-81649002RMTB01N5WX
Reference: RMTB01-AHG5E, RMTB01-AHG25E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01HNZE

AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01HNZE
Basic UDI-DI: B-81649002AMTBC01HNZE
Reference: AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01DNVDE

AMTBC01D-AHG48E, AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01DNVDE
Basic UDI-DI: B-81649002AMTBC01DNVDE
Reference: AMTBC01D-AHG48E, AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB-RIF Dx

601210025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139453
Basic UDI-DI: B-08908020139453
Reference: 601210025
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

601130025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139101
Basic UDI-DI: B-08908020139101
Reference: 601130025
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB-RIF Dx

601210050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989699
Basic UDI-DI: B-08908007989699
Reference: 601210050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB-RIF Dx

601210020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989682
Basic UDI-DI: B-08908007989682
Reference: 601210020
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB-RIF Dx

601210005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989675
Basic UDI-DI: B-08908007989675
Reference: 601210005, 601210020, 601210025, 601210050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

601130050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989484
Basic UDI-DI: B-08908007989484
Reference: 601130050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

601130005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989460
Basic UDI-DI: B-08908007989460
Reference: 601130005
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat MTB Plus

601130020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989477
Basic UDI-DI: B-08908007989477
Reference: 601130020
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ MTB/NTMe Real-time Detection

Anyplex™ MTB/NTMe Real-time Detection

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103838
Basic UDI-DI: B-08809240103838
Reference: TB10383Z
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ MTB/NTMe Real-time Detection

Anyplex™ MTB/NTMe Real-time Detection

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100516
Basic UDI-DI: B-08809240100516
Reference: TB7202X
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ MTB/NTMe Real-time Detection

Anyplex™ MTB/NTMe Real-time Detection

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100509
Basic UDI-DI: B-08809240100509
Reference: TB7202Y
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView TB MPCR-ULFA Kit

V0431

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500115
Basic UDI-DI: B-08800097500115
Reference: V0431
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView TB/NTM MPCR-ULFA Kit

V0401

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500009
Basic UDI-DI: B-08800097500009
Reference: V0401
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ MTB/NTM Real-time PCR Kit

PowerChek™ MTB/NTM Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056301005
Basic UDI-DI: B-08800056301005
Reference: IR0120
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion MTBC QLP 2.1 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740072
Basic UDI-DI: B-08698898740072
Reference: M0030102
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

Manufacturer products View details